HypertensionPhase 1NCT07838220
A Study of IBI3016 in Japanese Participants
A Phase 1 study testing IBI3016 Dose 4, IBI3016 Dose 3 and IBI3016 Dose 2 in people with Hypertension, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in Japan.
Trial summary
A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- IBI3016 Dose 4, IBI3016 Dose 3 and IBI3016 Dose 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2026to 5 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female participants aged 18-75 years (inclusive) at the time of informed consent;
- 2. Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin;
- 3. Office mean sitting SBP≥ 140 mmHg and < 170 mmHg at screening
Who cannot join
- 1. Participants with secondary hypertension, including but not limited to the following conditions: obstructive sleep apnea;
- 2. History of orthostatic hypotension
- 3. Current or history of intolerance to AECI, ARB, ARNI or direct renin inhibitor
- 4. With diseases that require treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors other than hypertension at screening;
- 5. Presence of serious active and uncontrolled physical conditions or medical history, which may be in a dangerous state during the use of the study drug, or interfere with the interpretation of efficacy and safety data of this study, as judged by the investigator prior to randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Congying Xia contact
Japan1 site, 1 recruiting
- Recruiting
Medical Corporation Heishinkai OPHAC Hospital
Osaka, 532-003
Kotaro Tsushima, +81-6-6395-9000, ophach_chiken@heishinkai.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of IBI3016 in Japanese Participants With Mild to Moderate Hypertension
A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.
- Conditions
- Hypertension
- Being tested
- IBI3016 Dose 4, IBI3016 Dose 3, IBI3016 Dose 2, IBI3016 Dose 1, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3016 Dose 4Drug
single doses of IBI3016 administered by subcutaneous injection
IBI3016 Dose 3Drug
single doses of IBI3016 administered by subcutaneous injection
IBI3016 Dose 2Drug
single doses of IBI3016 administered by subcutaneous injection
IBI3016 Dose 1Drug
single doses of IBI3016 administered by subcutaneous injection
PlaceboDrug
single doses of IBI3016 administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBI3016 Dose1 | Experimental | single doses of IBI3016 administered by subcutaneous injection Receives: Drug: IBI3016 Dose 1 |
| IBI3016 Dose 2 | Experimental | single doses of IBI3016 administered by subcutaneous injection Receives: Drug: IBI3016 Dose 2 |
| IBI3016 Dose4 | Experimental | single doses of IBI3016 administered by subcutaneous injection Receives: Drug: IBI3016 Dose 4 |
| Placebo | Placebo comparator | single doses of Placebo administered by subcutaneous injection Receives: Drug: Placebo |
| IBI3016 Dose3 | Experimental | single doses of IBI3016 administered by subcutaneous injection Receives: Drug: IBI3016 Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Through 24 weeks, up to approximately 12 months
Secondary outcomes (5)
Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016
Measured: Predose, early post-dose and up to 48 hours postdose
Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016
Measured: Predose, Day 1, and up to 48 hours postdose
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM
Measured: Baseline, Month 3 and Month 6
Change from baseline in serum angiotensinogen (AGT) concentration
Measured: Through 24 weeks, up to approximately 12 months
Urine PK parameter: drug accumulation
Measured: Predose, Day 1, and up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Aug 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion5 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838220
- Sponsor's protocol ID
- CIBI3016A103
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No